Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of tocilizumab versus placebo in polymyalgia rheumatica with glucocorticoid dependence semaphore

Conditions: Polymyalgia Rheumatica

Summary: patients are treated with infusions of tocilizumab (tcz) or placebo for 5 months. clinical evaluation is performed using pmr-as. the pmr-as is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: pmr-as (activity scale = as) = c reactive protein (crp) (mg/dl) + patient scale (vasp) (0-10 scale) + physician scale (vasph) (0-10 scale) + morning stiffness(mst) \[min\]×0.1) + elevation of upper limbs (eul) (0-3 scale). all the patients included are treated with glucocorticoid (gc).gc are reduced at each visit until the end of the study, depending on response to treatment and pmr-as.


Eligibility criteria:
inclusion criteria: * age older than 50 years * fulfilled the chuang criteria * and currently: * pmr-as\> 10 * absence of signs or symptoms of other musculoskeletal or connective tissue conditions * able to give informed consent * concomitant treatments with methotrexate or hydroxy-chloroquine are permitted if stable dose since 3 months. exclusion criteria: * clinical symptoms of giant cell arteritis * uncontrolled dyslipidemia, high blood pressure or cardiovascular disease * history of major organ or haematopoietic stem cell/marrow transplant * clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to pmr * planned surgical procedure within 12 months after randomization. * history of malignant neoplasm within the last 5 years. * current active infection * patient with elevated alt or ast\> 5 uln

Keywords: polymyalgia rheumatica tocilizumab glucocorticoid
pilot study evaluating functional and wellness outcomes of the shepherd can do ms program

Conditions: Multiple Sclerosis

Summary: the study evaluates the efficacy of the can do program for improving health, wellness, and quality of life in people with ms, and compares outcomes between people with ms who participate in the can do program to a control group of people with ms who do not participate in the can do program. the study also evaluates the impact of the can do program on support partners.

can do ms programs offer evidence-based, comprehensive, and personalized educational and experiential opportunities aimed at empowering and enabling a person with ms to live a healthy life beyond their ms. the signature program of can do ms is the four-day can do® program (can do). preliminary outcomes suggest that participation in can do leads to significant improvements in self-efficacy and various aspects of health status.1 the majority of 129 participants who participated in one of the three can do programs showed improvements in self-efficacy at one month (n=98), 3 months (n=84), and 6 months after the program (n=82; all p\<0.001). participants also showed significant improvements to varying degrees in subscales of the sf-36, including physical functioning (p=0.01), role physical, general health, vitality and mental health. these improvements were maintained to varying extents at one and 3 months post-program. these important outcomes have not yet been compared to those in people with ms who receive traditional care but do not participate in this comprehensive educational opportunity. furthermore, the impact on physical activity, participation, and quality of life has not been measured or compared to those who do not participate in can do. finally, recognizing the tremendous burden that can be placed on the support partner living and supporting a person with ms, education for support partners is another critical element of can do. however, the impact on the support partner of empowering an individual with ms to adopt healthy behaviors also has not been assessed. this project will allow shepherd center and can do ms to gather long-term health, wellness, and quality of life outcomes in people with ms and their support partners, as well as pilot data evaluating this study design for future larger scale clinical trials. demonstrating the efficacy of this program will provide evidence that will impact the lives of people with ms and their families, specifically, their ability to live healthy lives independent of their ms.

Eligibility criteria:
inclusion criteria: * can do program group: have ms and participated in the may 2019 shepherd can do program * cg-icms: have ms exclusion criteria: * can do program group: active members of the shepherd center ms wellness program, or who have previously been a participant in any can do ms programs. * cg-icms: cannot participate in any of the can do ms programs at any time prior to the study
therapeutic variables in cataract surgery

Conditions: Cataract Surgery

Summary: the purpose of this study is to compare patient outcomes in following cataract surgery in patients randomized to one of two surgical kits.


Eligibility criteria:
inclusion criteria: * males or females scheduled to undergo cataract surgery * patients can be receiving monofocal iols only * likely to complete all study visits and able to provide informed consent * visual potential of 20/25 or better exclusion criteria: * known contraindications to any study medication or ingredients * active ocular diseases or uncontrolled systemic disease * active ocular allergies
exploratory interventional study of prognostic serum biomarkers of cancer progression

Conditions: Melanoma; Non Small Cell Lung Cancer; Renal Cancer

Summary: exploratory interventional study of prognostic serum biomarkers of cancer progression. study of the relationship between the blood levels of soluble pdl1 and β2-microglobulin, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic of checkpoint immune inhibitor.

primary objective to study the relationship between the blood levels of soluble pdl1 and β2-microglobulin measured at the diagnostic stage, and the clinical course of a metastatic solid tumor (non-small cell lung cancer, kidney cancer, or melanoma) treated with a 1st line therapeutic immune checkpoint inhibitor. the secondary objectives are: * to study the relationship between the blood levels of soluble pdl1 and β2-microglobulin measured during treatment, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic immune checkpoint inhibitor. * to study the correlation between the soluble pdl1 level and the tumor pdl1 level. * to study the correlation between the blood levels of soluble pdl1 and β2-microglobulin. * to study the relationship between the blood levels of soluble pdl1 and β2-microglobulin measured during the treatment, and the tolerance of treatment with immune checkpoint inhibitor in 1st line therapy.

Eligibility criteria:
inclusion criteria: * adult patient, male or female, with metastatic cancer of the non-small cell, renal or malignant melanoma type, eligible for treatment with a first-line immune checkpoint inhibitor (immunotherapy alone or in combination with another immunotherapy, chemotherapy or targeted therapy). * affiliation to a social security organization * able to give informed consent to participate in research. exclusion criteria: * pregnant women * patient under guardianship, curatorship or legal protection * patient unable to understand the protocol (language barrier, cognitive difficulties) * patient with another active cancer * patient with creatinine clearance \<60 ml / min * patient participating in a therapeutic clinical trial * refusal of participation

Keywords: imunotherapy biomarkers prognostic
comparison of motor imagery technique and mime therapy on facial expressions in facial palsy patients

Conditions: Facial Palsy

Summary: this project was a randomized clinical trial conducted to compare the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients so that we can have best treatment option for patients of facial palsy. duration was of 6 months, convenient sampling was done, subjects following eligibility criteria from imran idrees teaching hospital and idrees hospital sialkot, were randomly allocated in two groups via computer generated method, baseline assessment was done, mit group received motor imagery technique, 45 min session (3 times a week for 3 months) plus the ems (10-15 min), while the mt group received mime therapy 30-45 min session (3 times a week for 3 months) plus the ems (10-15 min). outcome measures were collected for both groups at before treatment (t0) and at the end of the treatment i-e after 3 months (t1). the outcome measures were severity of paresis, facial symmetry and intensity of depression measured by using house-brackmann scale, sunnybrook facial grading system and beck depression inventory scale, respectively. data was analyzed by using spss version 24.0.

facial palsy is due to the damage in the facial nerve that supplies the muscles of the face. peripheral facial nerve paralysis can have various causes, such as bell's palsy, which is the most common cause. among secondary cause, tumors and the adverse effects of surgery for tumor pathologies such as, acoustic neuroma and facial nerve schwannoma are the most prevalent. the prognosis for fnp is complete recovery in roughly 80% of cases with bell's palsy, whereas 15% experiences some type of permanent nerve damage, with the remaining 5% enduring severe sequelae. to this end, fnp should be treated in a multidisciplinary setting, in which physical therapy, psychological and medical or surgical interventions are integrated. the current study has compared the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients. the current study was novel in a way that there is no evidence of superiority of any rehabilitative treatment compared with another in the recovery of fnp, which was clearly determined by the current study.

Eligibility criteria:
inclusion criteria: * unilateral facial palsy more than 6 months * age 20-60 years * house-brackmann scale score ≥3 * both genders exclusion criteria: * pregnant women * psychological treatment for any psychiatric disorder * participants with the history of any tumor * diabetes

Keywords: facial nerve palsy mime therapy motor imagery technique
phase ii axitinib (ag-013736) in elderly glioblastoma multiforme (gbm) patients

Conditions: Glioblastoma Multiforme

Summary: the purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.

the addition of axitinib to standard treatment is experimental and has not been approved by the united states food and drug administration (fda). axitinib works by preventing new blood vessels from forming, and tumors need to make new blood vessels in order to grow. the study will find out what effects, good or bad, axitinib has on the tumor. in addition, this study will try to determine whether the response to axitinib and the overall outcome depends on certain characteristics of your tumor.

Eligibility criteria:
inclusion criteria: * newly diagnosed patients with histologically proven glioblastoma multiforme * age above 70 years * karnofsky score of 50-80 * adequate organ function as defined by laboratory values * life expectancy of \>12 weeks * no evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. the baseline systolic blood pressure readings must be 140 mm hg, and the baseline diastolic blood pressure readings must be 90 mm hg. patients whose hypertension is controlled by antihypertensive therapies are eligible. exclusion criteria: * prior treatment with chemotherapy or radiation for glioblastoma multiforme * patients with extensive tumor hemorrhage * any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism

Keywords: gbm brain tumor
adequate definition of delayed graft function in living and deceased donor kidney transplantation

Conditions: Deceased Donor Kidney Transplantation; Living Donor Kidney Transplantation

Summary: it is required to establish an adequate definition of delayed graft function in deceased donor kidney transplantation. we attempt to compare various definitions of delayed graft function and find the definition that can predict graft function survival best in deceased donor kidney transplantation.

delayed graft function after kidney transplantation has been reported to be an important predictor for poor short and long-term survival. delayed graft function increases post-transplantation morbidity, hospital stay, and incidence of premature graft failure. however, the definition of delayed graft function varies and more than ten definitions have been used in previous studies. although the definition using dialysis requirements during seven days after transplantation has been used most frequently, dialysis may be required without any evidence of renal damage during one week after transplantation. furthermore, the incidence of delayed graft function in living donor kidney transplantation using this definition has been reported to be relatively low (as low as 1.6%) compared with the incidence in deceased donor kidney transplantation (up to 50%). therefore, it is required to establish a better definition of delayed graft function in deceased donor kidney transplantation. we attempt to compare various definitions of delayed graft function in deceased donor kidney transplantation and find the definition that can predict graft function survival best in deceased donor kidney transplantation.

Eligibility criteria:
inclusion criteria: * patients who underwent living or deceased donor kidney transplantation between 2008 and 2013 exclusion criteria: * incomplete data of postoperative creatinine during ten days after transplantation or postoperative urine output during three days after transplantation * patients who underwent retransplantation * patients who expired for reasons other than kidney transplantation

Keywords: kidney transplantation delayed graft function creatinine graft survival
gemcitabine and oxaliplatin in treating patients with locally advanced or metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.

objectives: i. determine the objective tumor response rate in patients with locally advanced or metastatic pancreatic carcinoma when treated with gemcitabine and oxaliplatin. ii. determine the tolerablility and clinical benefit of this regimen in these patients. iii. evaluate the progression free survival and the overall survival of these patients when treated with this regimen. outline: this is a multicenter study. patients receive gemcitabine iv on day 1 over 1.5 hours and oxaliplatin iv over 2 hours on day 2. treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. patients with locally advanced disease receive 6-8 courses and then may undergo surgery, radiotherapy, and/or additional chemotherapy. projected accrual: a total of 66 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed metastatic or locally advanced unresectable adenocarcinoma of the pancreas measurable disease at least 2 cm in diameter no known brain metastases patient characteristics: age: 18 to 75 performance status: ecog 0-2 or karnofsky 60-100% life expectancy: greater than 12 weeks hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) alkaline phosphatase no greater than 5 times uln renal: creatinine no greater than 1.5 times uln cardiovascular: adequate cardiac function pulmonary: adequate respiratory function other: not pregnant or nursing fertile patients must use effective contraception no sensitive neuropathy no other active malignancy no uncontrolled hypercalcemia no significant medical or psychiatric condition that would preclude study no psychological, familial, sociological, or geographical condition that would preclude study prior concurrent therapy: biologic therapy: no prior immunotherapy chemotherapy: no prior chemotherapy endocrine therapy: no concurrent corticosteroid use except as antiemetic radiotherapy: no prior radiotherapy surgery: not specified other: no other concurrent investigational drugs

Keywords: stage iii pancreatic cancer stage iv pancreatic cancer adenocarcinoma of the pancreas
retrospective study on referral patterns for high risk patients post nephrectomy

Conditions: Renal Cell Carcinoma

Summary: this study aims at estimating the proportion of patients diagnosed with locoregional renal cell carcinoma who are at high risk for recurrence following nephrectomy, describe referral patterns, and characterize treatment in this population. outcomes including estimation of the incidence of recurrence and disease-free interval following nephrectomy will be reported overall and among the subgroup off patients receiving adjuvant systemic therapy with sunitinib following nephrectomy.


Eligibility criteria:
inclusion criteria: * patients must meet all of the following inclusion criteria to be eligible for data abstraction: * diagnosed with locoregional rcc (no distant metastasis at the time of diagnosis) * underwent a nephrectomy at duke between 01 april 2014, and 31 december 2019 (final dates determined based on results from part 2 data collection) * aged 18 years or older at nephrectomy exclusion criteria: * none
managerial database ii

Conditions: Acquired Immunodeficiency Syndrome

Summary: this study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of hiv positive adolescents receiving care at sites newly participating in atn iii.

the proposed study is a cross sectional study intended to be conducted at each of the adolescent medicine trials units (amtus) newly participating in atn iii and to enroll all participating patients followed at each site. this approach will allow for the examination of the broad spectrum of youth participating in the atn, including those newly entered into care. psychosocial and risk-taking behavioral data will be collected using audio computer-assisted self-interview (acasi) for english-speaking participants, or a paper-and-pencil spanish-language survey with identical measures to the acasi for spanish-speaking participants; biomedical information will be collected through medical chart abstraction.

Eligibility criteria:
inclusion criteria: * laboratory evidence of hiv-1 infection documented by a positive result on any of the following licensed tests at any time: any hiv-1 antibody test confirmed by western blot, hiv-1 culture, hiv-1 dna pcr, or plasma hiv-1 rna pcr \> 1,000 copies/ml; * knowledge of hiv positive diagnoses; * age 12 years through 24 years, inclusive, at the time of consent; * engaged in care at the amtu or its affiliate and/or partnering clinic. individuals will be considered to be engaged in care if they have an amtu (or its affiliate) clinic visit during the enrollment period; * ability to understand written and/or verbal english or spanish. exclusion criteria: * presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to complete the study measures; * visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior); or * intoxicated or under the influence of alcohol or other substances at the time of consent/assent

Keywords: medication adherence substance use sexual risk behaviors
clinical efficacy and safety of incadronate in breast cancer with bone metastases

Conditions: Breast Cancer; Bone Metastases

Summary: this is a real-world study to explore the efficacy and safety of incadronate in the treatment of breast cancer patients with bone metastases.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 years or above; 2. can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent 3. the physical status score of the eastern cooperative oncology group (ecog) was ≤3; 4. histologically or cytologically confirmed breast cancer; 5. imaging or histocytology confirmed bone metastases; 6. there were indications of useing incadronate and no contraindications in the use of incadronate; 7. new york heart association（nyha）cardiac function grade ≤ii, no serious heart disease; 8. all women of childbearing age, fertile men or their spouses did not plan to have children or donate sperm throughout the trial period until 6 months after the last dose, or voluntarily took effective contraceptive measures. exclusion criteria: 1. pregnant or lactating women; 2. patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study; 3. other malignant tumors within 5 years (except the following cases: cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma; a second primary cancer that has been eradicated and has not recurred within five years; investigators have identified the primary tumor source of the metastases); 4. mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response; 5. there are serious organic diseases or major organ failure, such as decompensated heart, lung, liver, kidney failure, which can not tolerate treatment; 6. patients with bleeding tendency; 7. the researcher believes that the patient has other conditions that are not suitable for participating in this study.